BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SPINBRUSH PROCLEAN SONIC POWERED TOOTHBRUSH

    MDR report key: 2432871 · Received January 11, 2012

    Report

    Report Number
    2280705-2012-00007
    Event Type
    Malfunction
    Date Received
    January 11, 2012
    Date of Event
    December 13, 2011
    Report Date
    January 11, 2012
    Manufacturer
    CHURCH & DWIGHT CO., INC.
    Product Code
    JEQ
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE MANUFACTURE DATE: HANDLE: 01/16/2010, HEAD 10/11/2009. THE BODY WAS MADE AT THE FOLLOWING LOCATION: HAYCO LTD., (B)(4).

    Description of Event or Problem · 1

    CONSUMER REPORTED THAT THE HEAD OF THE SONIC TOOTHBRUSH DISENGAGED DURING USE. THIS IS REGARDED AS A MALFUNCTION. THE INCIDENT CASE CAUSED THE CONSUMER TO CHIP A TOOTH AND WAS REPORTED AS 2280705-2011-00014. NOTE: THIS REPORT IS A RESULT OF A TELECONFERENCE BETWEEN CHURCH & DWIGHT CO., INC AND THE MEDICAL DEVICE POLICY BRANCH ON SEPT 20, 2011, WHERE CLARIFICATION WAS PROVIDED ON "REPORTABLE MALFUNCTIONS." THIS ENTAILED REVIEWING CONSUMER COMPLAINT FILES FROM JAN 2009 TO DEC 2011 TO IDENTIFY AND SUBMIT ALL MEETING THESE CRITERIA.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SPINBRUSH PROCLEAN SONIC POWERED TOOTHBRUSH TOOTHBRUSH, POWERED 872.6865 (JEQ) JEQ CHURCH & DWIGHT CO., INC. 6687800940 HANDLE DD0016L1 HEAD 92841C

    Patients

    Seq Age Sex Outcome Treatment
    1